Call for proposals for a programme on orphan medical devices, in particular targeting paediatric patients
Programme Category
Programme Name
Programme Description
The Programme aims to improve and promote health in the Union to reduce the burden of communicable and non-communicable diseases by:
- protecting people from serious cross-border health threats
- improving the availability, accessibility and affordability of medicines, medical devices and other crisis-related products in the EU
- strengthening national health systems
Identifier Code
Call
Summary
This action aims to support innovation in the field of medical devices by supporting non-profit organisations or consortia that provide a platform for academic bodies, scientific societies, developers of devices, in particular SMEs, and NGOs with a specific interest in innovative medical devices to help foster and guide the development of orphan devices, in particular in areas of unmet medical needs and paediatric patients.
Detailed Call Description
A wide range of activities can be funded that support, among other things, the development, design, production and distribution or orphan devices, including intellectual property advising, prototyping, engineering, laboratory and animal testing, grant-writing, and clinical investigation design.
The eligible entities should facilitate the development, production, and distribution of orphan devices, in particular for paediatric patients by:
a) mapping unmet medical needs that could be addressed by orphan devices;
b) encouraging innovation and connecting relevant players (e.g., academia, scientific societies, users) with orphan device ideas with potential manufacturers;
c) mentoring and managing orphan device projects through the development process, including product identification, prototype design, device development, and marketing;
d) connecting developers of innovative devices and physicians to existing financing resources;
e) assessing the scientific and medical merit of proposed orphan device projects;
f) gathering and evaluating pre-clinical data to support the safety and/or performance of the orphan device; g) providing assistance and advice as needed on business development, personnel training, prototype development, intellectual property protection and post-marketing needs;
h) advising about regulatory requirements to device developers in support of achieving CE marking for the orphan devices; and
i) supporting the demonstration of conformity with the relevant requirements laid down in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 with a view to allowing the CE marking of the product building on the guidance MDCG 2024-10 including the scientific advice procedure from the expert panels on medical devices
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
Indicative project budget: €300.000 – €400.000
The costs will be reimbursed at the funding rate fixed in the Grant Agreement (60%).
You can apply for a higher project funding rate (80%) if your project is of ‘exceptional utility’, i.e. concerns:
- actions where at least 30 % of the budget is allocated to Member States (or EU4H associated countries) whose GNI per inhabitant is less than 90% of the EU average or
- actions with bodies from at least 14 Member States (or EU4H associated countries) and where at least four are from Member States (or EU4H associated countries) whose GNI per inhabitant is less than 90% of the EU average.
Grants may NOT produce a profit (i.e. surplus of revenues + EU grant over costs).
For-profit organisations must declare their revenues and, if there is a profit, we will deduct it from the final grant amount.
Thematic Categories
- Health
- Research, Technological Development and Innovation
Eligibility for Participation
- Associations
- Businesses
- Educational Institutions
- Large Enterprises
- Legal Entities
- NGOs
- Non Profit Organisations
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- Semi-governmental organisations
- Small and Medium Enterprises (SMEs)
- State-owned Enterprises
Eligibility For Participation Notes
In order to be eligible, the applicants (beneficiaries and affiliated entities) must be legal entities (public or private bodies) established in EU Member States (including overseas countries and territories (OCTs)) or EEA countries and countries associated to the EU4Health Programme (list of participating countries).
For topic EU4H-2026-SANTE-PJ-07: Proposals may be submitted either by a single applicant or by a consortium (no minimum requirement).
Type of applicants targeted: Academia and education establishments, research institutes, hospitals, expert networks including ERNs; civil society organisations: associations, foundations, NGOs, enterprises (including social enterprises and not for profit) in the field of public health, private entities (for profit, not for profit).
Call Opening Date
Call Closing Date
National Contact Point(s)
Ministry of Health, Department of European Affairs
Telephone: 22605300/301, 22605617, 22605718
Address: Corner of Prodromou 1 & Chilonos 17 1448 Nicosia, Cyprus
Ms MAKRIGIORGI Elena
Email: emakrigiorgi@moh.gov.cy